Table of contents
- Trial overview
- Surgery studies
- Headache study
- Obesity and anesthesia study
- Main endpoints being measured
- Trial design, phase, and enrollment
- Patient guide to key terms
Trial overview
The trial data show several interventional studies that include Magnesium Sulfate Heptahydrate as part of the study treatment.[1] The main focus is on how it performs in real clinical settings, especially surgery and severe headache care.[1]
Most of the Magnesium Sulfate Heptahydrate studies in this set are Phase 3 trials, which are later-stage studies used to check how well a treatment works and how safe it is in larger groups.[1] The studies are listed as interventional, meaning the researchers actively give a treatment and then measure the results.[1]
Surgery studies
One authorised Phase 3 trial is studying patients having lung resection surgery using Video-Assisted Thoracic Surgery (VATS).[1] The trial asks whether intravenous lidocaine and Magnesium Sulfate Heptahydrate during surgery can reduce morphine use in the first 24 hours after the operation.[1]
This study plans to enroll 128 participants and uses morphine consumption as its primary outcome.[1] For patients, this means the researchers want to know if the study treatment can lower the need for extra pain medicine after surgery.[1]
Another authorised Phase 3 trial in the data looks at robotic bariatric surgery in patients with obesity, but it is currently suspended and does not appear to be a Magnesium Sulfate Heptahydrate-specific trial in the source data.[1] It is included here because the intervention list contains Magnesium Sulfate Heptahydrate among other study drugs.[1]
Headache study
The completed Phase 3 trial NCT04814381 studied people with refractory chronic cluster headache, which means a severe headache condition that had not improved with recommended treatments.[1] The study tested a single infusion of ketamine combined with Magnesium Sulfate Heptahydrate against an active placebo group that received hydroxyzine.[1]
The main outcome was the change in weekly frequency of headache crises during days 7 to 13 compared with the period before treatment.[1] This tells patients that the trial was looking for fewer headache attacks after treatment, not just short-term symptom relief.[1]
This study enrolled 90 participants and was designed as an interventional Phase 3 trial.[1] The brief summary says the goal was to evaluate whether the infusion helped reduce headache crises in patients who were not relieved by currently recommended treatments.[1]
Obesity and anesthesia study
The suspended Phase 3 ANGELO study is in patients with obesity undergoing robotic bariatric surgery.[1] The study compares opioid-free general anesthesia with opioid-based general anesthesia to see whether it lowers postoperative nausea and vomiting.[1]
Magnesium Sulfate Heptahydrate is listed among the study drugs in this trial, along with lidocaine, dexmedetomidine, and ketamine.[1] The primary outcome is the Visual Analog Scale for Nausea (VAS-N), which is a patient score for how strong nausea feels.[1]
This study planned to enroll 64 participants.[1] Because the trial is suspended, it is not currently moving forward in the same way as the authorised studies.[1]
Main endpoints being measured
The trials use endpoints, which are the main results researchers measure to answer the study question.[1] In the lung surgery trial, the endpoint is morphine use in the first 24 postoperative hours.[1]
In the chronic cluster headache trial, the endpoint is the change in weekly headache crisis frequency.[1] In the bariatric surgery trial, the endpoint is nausea severity measured with the VAS-N score.[1]
Some trials in the broader data also focus on safety, using outcomes such as treatment-emergent adverse events and serious adverse events.[1] These are medical events that happen after treatment starts, and serious adverse events are the more severe ones.[1]
Trial design, phase, and enrollment
All of the Magnesium Sulfate Heptahydrate studies shown here are interventional trials, so the treatment is actively given as part of the study plan.[1] The studies are mainly Phase 3, with enrollment sizes ranging from 64 to 128 in the Magnesium Sulfate Heptahydrate-related trials listed above.[1]
The target populations are very different, which shows that the trials are studying Magnesium Sulfate Heptahydrate in more than one clinical setting.[1] These include surgical patients, patients with severe headache, and patients with obesity undergoing bariatric surgery.[1]
The status of the trials also varies, with authorised, completed, and suspended studies in the data.[1] This means some studies are active or approved, one has finished, and one is currently on hold.[1]
Patient guide to key terms
Authorised means the study has been approved to move forward.[1] Completed means the study has finished collecting data.[1] Suspended means the study has been paused.[1]
Intravenous infusion means a treatment is given through a vein over time.[1] Intraoperative means during surgery, and postoperative means after surgery.[1]
Active placebo means a control treatment that may cause some effects but is not the main study treatment.[1] This helps researchers compare results more fairly in some trials.[1]
